title: A feasibility study of immediate versus deferred antiretroviral therapy in children with HIV infection.
abstract: OBJECTIVE
  To evaluate the feasibility of a large immediate versus deferred antiretroviral therapy (ART) study in children.
  
  
  METHODS
  We conducted an open-label pilot randomized clinical trial study in 43 Thai children with CD4 15 to 24% of starting generic AZT/3TC/NVP immediately (Arm 1) or deferring until CD4 < 15% or CDC C (Arm 2). Primary endpoints were recruitment rate, adherence to randomized treatment and retention in trial. Secondary endpoints were % with CDC C or CD4 < 15%. Children were in the trial until the last child reached 108 weeks. Intention to treat and on treatment analyses were performed.
  
  
  RESULTS
  Recruitment took 15 months. Twenty-six of 69 (37.7%) were not eligible due mainly to low CD4%. Twenty four and 19 were randomized to arms 1 and 2 respectively. All accepted the randomized arm; however, 3 in arm 1 stopped ART and 1 in arm 2 refused to start ART. Ten/19 (53%) in arm 2 started ART. At baseline, median age was 4.8 yrs, CDC A:B were 36:7, median CD4 was 19% and viral load was 4.8 log. All in arm 1 and 17/19 in arm 2 completed the study (median of 134 weeks). No one had AIDS or death. Four in immediate arm had tuberculosis. Once started on ART, deferred arm children achieved similar CD4 and viral load response as the immediate arm. Adverse events were similar between arms. The deferred arm had a 26% ART saving.
  
  
  CONCLUSIONS
  Almost 40% of children were not eligible due mainly to low CD4% but adherence to randomized treatment and retention in trial were excellent. A larger study to evaluate when to start ART is feasible.
authors.affiliation: HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Center, Bangkok, Thailand. jintanat.a@hivnat.org
authors.forename: Jintanat
authors.initials: J
authors.lastname: Ananworanich
authors.forename: Pope
authors.initials: P
authors.lastname: Kosalaraksa
authors.forename: Umaporn
authors.initials: U
authors.lastname: Siangphoe
authors.forename: Chulapan
authors.initials: C
authors.lastname: Engchanil
authors.forename: Chitsanu
authors.initials: C
authors.lastname: Pancharoen
authors.forename: Pagakrong
authors.initials: P
authors.lastname: Lumbiganon
authors.forename: Jintana
authors.initials: J
authors.lastname: Intasan
authors.forename: Wichitra
authors.initials: W
authors.lastname: Apateerapong
authors.forename: Theshinee
authors.initials: T
authors.lastname: Chuenyam
authors.forename: Sasiwimol
authors.initials: S
authors.lastname: Ubolyam
authors.forename: Torsak
authors.initials: T
authors.lastname: Bunupuradah
authors.forename: Joep
authors.initials: J
authors.lastname: Lange
authors.forename: David A
authors.initials: DA
authors.lastname: Cooper
authors.forename: Praphan
authors.initials: P
authors.lastname: Phanuphak